PUBLISHER: The Business Research Company | PRODUCT CODE: 2133528
PUBLISHER: The Business Research Company | PRODUCT CODE: 2133528
Artificial intelligence (AI) in in vitro diagnostics (IVD) refers to the application of advanced algorithms to analyze medical data generated from laboratory tests conducted on samples such as blood, tissue, or urine. It enables faster, more accurate, and data-driven interpretation of test results, supporting early disease detection, personalized treatment decisions, and enhanced diagnostic efficiency.
The main components of artificial intelligence (AI) in in vitro diagnostics (IVD) include software, hardware, and services. Software is a set of programs and data that enables a computer to perform specific tasks. It utilizes technologies such as machine learning, natural language processing, computer vision, robotic process automation, and deep learning, and is deployed through cloud-based, on-premise, and hybrid methods. These technologies are applied in areas including diagnostic imaging, laboratory testing, pathology, genomics, and personalized medicine, and cater to end users such as hospitals and clinics, diagnostic laboratories, research institutes, pharmaceutical companies, and medical device manufacturers.
Tariffs are affecting the AI in vitro diagnostics market by increasing the costs of importing laboratory instruments, diagnostic software, and biomarker testing kits, particularly across the Asia-Pacific and European regions. Hardware-intensive segments such as laboratory instruments and imaging devices are most affected, resulting in delays and higher operational costs for diagnostic laboratories. On the positive side, tariffs are encouraging local production and innovation, leading to more cost-efficient AI-based diagnostic solutions and strengthening regional manufacturing capabilities.
The artificial intelligence (AI) in in vitro diagnostics (ivd) market research report is one of a series of new reports from The Business Research Company that provides artificial intelligence (AI) in in vitro diagnostics (ivd) market statistics, including artificial intelligence (AI) in in vitro diagnostics (ivd) industry global market size, regional shares, competitors with a artificial intelligence (AI) in in vitro diagnostics (ivd) market share, detailed artificial intelligence (AI) in in vitro diagnostics (ivd) market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence (AI) in in vitro diagnostics (ivd) industry. This artificial intelligence (AI) in in vitro diagnostics (ivd) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The artificial intelligence (AI) in in vitro diagnostics (ivd) market size has grown exponentially in recent years. It will grow from $0.53 billion in 2025 to $0.64 billion in 2026 at a compound annual growth rate (CAGR) of 20.2%. The growth in the historic period can be attributed to increasing demand for accurate diagnostics, expansion of laboratory infrastructure, rising prevalence of chronic diseases, growing adoption of digital diagnostic tools, and advancements in biomarker research.
The artificial intelligence (AI) in in vitro diagnostics (ivd) market size is expected to see rapid growth in the next few years. It will grow to $1.33 billion in 2030 at a compound annual growth rate (CAGR) of 19.8%. The growth during the forecast period can be attributed to the expansion of cloud-based diagnostic platforms, increasing integration of AI with genomics, development of AI-enabled point-of-care diagnostics, growing investments in personalized medicine, and rising demand for rapid and cost-effective testing. Major trends during the forecast period include AI-enabled laboratory automation, predictive disease diagnostics, data-driven test interpretation, expansion of cloud-based diagnostic platforms, and personalized patient profiling.
The increasing demand for personalized medicine is anticipated to support the growth of artificial intelligence (AI) in the in vitro diagnostics (IVD) market going forward. Personalized medicine refers to a healthcare approach that tailors prevention, diagnosis, and treatment according to an individual's genetic profile, lifestyle, and environmental factors. Personalized medicine is expanding as advancements in genomic data and sequencing technologies enable more accurate, targeted, and effective treatments that are customized to individual patients. Artificial intelligence (AI) in in vitro diagnostics (IVD) supports personalized medicine by analyzing complex diagnostic information to identify patient-specific disease patterns, enabling accurate, timely, and customized treatment decisions. For instance, in February 2024, according to the Personalized Medicine Coalition, a US-based non-profit organization, in 2023, the FDA approved 16 new personalized treatments for patients with rare diseases, compared with six in 2022. The newly approved personalized treatments in 2023 also included seven cancer drugs and three treatments for other diseases and conditions. Therefore, the increasing demand for personalized medicine is driving the growth of artificial intelligence (AI) in the in vitro diagnostics (IVD) market.
Key companies operating in the artificial intelligence (AI) in in vitro diagnostics (IVD) market are focusing on developing advanced solutions, such as CE-IVDR-certified transparent AI platforms, to improve diagnostic accuracy, streamline workflows, and support personalized patient care. A CE-IVDR-certified transparent AI platform is an AI system used for in vitro diagnostics that complies with EU regulatory standards and provides clear, auditable, and understandable decision-making processes. For example, in May 2025, Diagnostics.ai, a UK-based diagnostic testing company, launched PCR.AI, a smart solution designed to accelerate and improve PCR diagnostics. The solution automates and accelerates the interpretation of real-time PCR diagnostics with more than 99.9% accuracy. It provides transparency by clearly demonstrating how each result is generated, supporting regulatory compliance and increasing clinical trust. This substantially improves laboratory efficiency, minimizes errors, and enables seamless regulatory adherence for molecular diagnostics.
In April 2025, bioMerieux SA, a France-based technology company specializing in artificial intelligence (AI) for in vitro diagnostics (IVD), entered into a partnership with Mila to advance AI-driven diagnostic research and innovation. This partnership aims to develop advanced AI solutions that improve the accuracy and efficiency of in vitro diagnostic tools and enhance the detection of antibiotic resistance. Mila is a Canada-based artificial intelligence research institute recognized for its cutting-edge research in machine learning.
Major companies operating in the artificial intelligence (AI) in in vitro diagnostics (ivd) market are Roche Diagnostics GmbH, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthineers AG, Illumina Inc., Hologic Inc., Sysmex Corporation, QIAGEN N.V., Tempus Labs Inc., BillionToOne Inc., PathAI Inc., Proscia Inc., Indica Labs Inc., Visiopharm A/S, aetherAI Co. Ltd., Ibex Medical Analytics Ltd., Mindpeak GmbH, OncoHost Ltd., Qritive, Aiforia Technologies Oyj
North America was the largest region in the artificial intelligence (AI) in in vitro diagnostics (IVD) market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the artificial intelligence (AI) in in vitro diagnostics (ivd) market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the artificial intelligence (AI) in in vitro diagnostics (ivd) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The artificial intelligence (AI) in in vitro diagnostics (IVD) market includes revenues earned by entities by providing services such as predictive analytics services, remote diagnostic and telepathology services, workflow automation, optimization services, data annotation, and clinical decision support services. The market value includes the value of related goods sold by the service provider or included within the service offering. The artificial intelligence (AI) in in vitro diagnostics (IVD) market also includes sales of automated laboratory instruments, artificial intelligence-enabled digital pathology scanners, and liquid biopsy diagnostic kits. Values in this market are 'factory gate' values; that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Artificial Intelligence (AI) In In Vitro Diagnostics (IVD) Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses artificial intelligence (ai) in in vitro diagnostics (ivd) market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for artificial intelligence (ai) in in vitro diagnostics (ivd) ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The artificial intelligence (ai) in in vitro diagnostics (ivd) market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
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